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Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation

1 dicembre 2016 aggiornato da: GlaxoSmithKline

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Lovaza for the Prevention of Recurrent, Symptomatic Atrial Fibrillation

The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

663

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35215
        • GSK Investigational Site
      • Huntsville, Alabama, Stati Uniti, 35801
        • GSK Investigational Site
    • Alaska
      • Anchorage, Alaska, Stati Uniti, 99508
        • GSK Investigational Site
    • Arizona
      • Cottonwood, Arizona, Stati Uniti, 86326
        • GSK Investigational Site
      • Mesa, Arizona, Stati Uniti, 85206
        • GSK Investigational Site
      • Phoenix, Arizona, Stati Uniti, 85006
        • GSK Investigational Site
      • Phoenix, Arizona, Stati Uniti, 85032
        • GSK Investigational Site
      • Phoenix, Arizona, Stati Uniti, 85014
        • GSK Investigational Site
      • Tucson, Arizona, Stati Uniti, 85724
        • GSK Investigational Site
    • Arkansas
      • Fort Smith, Arkansas, Stati Uniti, 72901
        • GSK Investigational Site
      • Hot Springs, Arkansas, Stati Uniti, 71913
        • GSK Investigational Site
    • California
      • Alamada, California, Stati Uniti, 94501
        • GSK Investigational Site
      • Bakersfield, California, Stati Uniti, 93301
        • GSK Investigational Site
      • Bakersfield, California, Stati Uniti, 93308
        • GSK Investigational Site
      • Beverly Hills, California, Stati Uniti, 90210
        • GSK Investigational Site
      • Carmichael, California, Stati Uniti, 95608
        • GSK Investigational Site
      • Fair Oaks, California, Stati Uniti, 95628
        • GSK Investigational Site
      • Fountain Valley, California, Stati Uniti, 92708
        • GSK Investigational Site
      • Loma Linda, California, Stati Uniti, 92354
        • GSK Investigational Site
      • Los Angeles, California, Stati Uniti, 90073
        • GSK Investigational Site
      • Los Angeles, California, Stati Uniti, 90048
        • GSK Investigational Site
      • Los Angeles, California, Stati Uniti, 90033
        • GSK Investigational Site
      • Los Angeles, California, Stati Uniti, 90211
        • GSK Investigational Site
      • Merced, California, Stati Uniti, 95348
        • GSK Investigational Site
      • Palm Springs, California, Stati Uniti, 92262
        • GSK Investigational Site
      • Poway, California, Stati Uniti, 92064
        • GSK Investigational Site
      • Redondo Beach, California, Stati Uniti, 90277
        • GSK Investigational Site
      • Sacramento, California, Stati Uniti, 95819
        • GSK Investigational Site
      • San Diego, California, Stati Uniti, 92123
        • GSK Investigational Site
      • San Diego, California, Stati Uniti, 92120
        • GSK Investigational Site
      • San Diego, California, Stati Uniti, 92161
        • GSK Investigational Site
      • Vista, California, Stati Uniti, 92081
        • GSK Investigational Site
      • Walnut Creek, California, Stati Uniti, 94598
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80012
        • GSK Investigational Site
      • Colorado Springs, Colorado, Stati Uniti, 80907
        • GSK Investigational Site
      • Littleton, Colorado, Stati Uniti, 80120
        • GSK Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, Stati Uniti, 06606
        • GSK Investigational Site
      • Farmington, Connecticut, Stati Uniti, 06030
        • GSK Investigational Site
      • Guilford, Connecticut, Stati Uniti, 06437
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20010
        • GSK Investigational Site
      • Washington, District of Columbia, Stati Uniti, 20017
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, Stati Uniti, 33180
        • GSK Investigational Site
      • Bay Pines, Florida, Stati Uniti, 33744
        • GSK Investigational Site
      • Daytona Beach, Florida, Stati Uniti, 32114
        • GSK Investigational Site
      • Delray Beach, Florida, Stati Uniti, 33484
        • GSK Investigational Site
      • Fort Meyers, Florida, Stati Uniti, 33919
        • GSK Investigational Site
      • Gainesville, Florida, Stati Uniti, 32605
        • GSK Investigational Site
      • Hudson, Florida, Stati Uniti, 34667
        • GSK Investigational Site
      • Jacksonville, Florida, Stati Uniti, 32216
        • GSK Investigational Site
      • Jacksonville, Florida, Stati Uniti, 32207
        • GSK Investigational Site
      • Jupiter, Florida, Stati Uniti, 33458
        • GSK Investigational Site
      • Kissimmee, Florida, Stati Uniti, 34741
        • GSK Investigational Site
      • Largo, Florida, Stati Uniti, 33773
        • GSK Investigational Site
      • Melbourne, Florida, Stati Uniti, 32901
        • GSK Investigational Site
      • Miami, Florida, Stati Uniti, 33136
        • GSK Investigational Site
      • Miami, Florida, Stati Uniti, 33137
        • GSK Investigational Site
      • Miami, Florida, Stati Uniti, 33176
        • GSK Investigational Site
      • Ocala, Florida, Stati Uniti, 34471
        • GSK Investigational Site
      • Orlando, Florida, Stati Uniti, 32803
        • GSK Investigational Site
      • Ormond Beach, Florida, Stati Uniti, 32174
        • GSK Investigational Site
      • Pensacola, Florida, Stati Uniti, 32514
        • GSK Investigational Site
      • Pinellas Park, Florida, Stati Uniti, 33781
        • GSK Investigational Site
      • Tampa, Florida, Stati Uniti, 33607
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, Stati Uniti, 30322
        • GSK Investigational Site
      • Atlanta, Georgia, Stati Uniti, 30328
        • GSK Investigational Site
      • Decatur, Georgia, Stati Uniti, 30030
        • GSK Investigational Site
      • Tucker, Georgia, Stati Uniti, 30084
        • GSK Investigational Site
    • Illinois
      • Bannockburn, Illinois, Stati Uniti, 60015
        • GSK Investigational Site
      • Gurnee, Illinois, Stati Uniti, 60031
        • GSK Investigational Site
      • Normal, Illinois, Stati Uniti, 61761
        • GSK Investigational Site
      • Peoria, Illinois, Stati Uniti, 61603
        • GSK Investigational Site
    • Indiana
      • Elkhart, Indiana, Stati Uniti, 46514
        • GSK Investigational Site
      • Indianapolis, Indiana, Stati Uniti, 46260
        • GSK Investigational Site
      • La Porte, Indiana, Stati Uniti, 46350
        • GSK Investigational Site
      • South Bend, Indiana, Stati Uniti, 46601
        • GSK Investigational Site
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66102
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40205
        • GSK Investigational Site
      • Mount Sterling, Kentucky, Stati Uniti, 40353
        • GSK Investigational Site
    • Louisiana
      • Covington, Louisiana, Stati Uniti, 70433
        • GSK Investigational Site
      • Lacombe, Louisiana, Stati Uniti, 70445
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, Stati Uniti, 04210
        • GSK Investigational Site
      • Biddeford, Maine, Stati Uniti, 04005
        • GSK Investigational Site
      • Portland, Maine, Stati Uniti, 04106
        • GSK Investigational Site
      • Scarborough, Maine, Stati Uniti, 04074
        • GSK Investigational Site
    • Maryland
      • Annapolis, Maryland, Stati Uniti, 20401
        • GSK Investigational Site
    • Massachusetts
      • Ayer, Massachusetts, Stati Uniti, 01432
        • GSK Investigational Site
      • Brookline, Massachusetts, Stati Uniti, 02446
        • GSK Investigational Site
      • Worcester, Massachusetts, Stati Uniti, 01655
        • GSK Investigational Site
    • Michigan
      • Alpena, Michigan, Stati Uniti, 49707
        • GSK Investigational Site
      • Cadillac, Michigan, Stati Uniti, 49601
        • GSK Investigational Site
      • Detroit, Michigan, Stati Uniti, 48201
        • GSK Investigational Site
      • Kalamazoo, Michigan, Stati Uniti, 49048
        • GSK Investigational Site
      • Lansing, Michigan, Stati Uniti, 48910
        • GSK Investigational Site
    • Minnesota
      • Mineappolis, Minnesota, Stati Uniti, 55417
        • GSK Investigational Site
      • Rochester Hills, Minnesota, Stati Uniti, 48307
        • GSK Investigational Site
      • St Paul, Minnesota, Stati Uniti, 55102
        • GSK Investigational Site
    • Mississippi
      • Gulfport, Mississippi, Stati Uniti, 39503
        • GSK Investigational Site
    • Montana
      • Billings, Montana, Stati Uniti, 59101
        • GSK Investigational Site
      • Kalispell, Montana, Stati Uniti, 59901
        • GSK Investigational Site
      • Missoula, Montana, Stati Uniti, 59802
        • GSK Investigational Site
    • New Jersey
      • Morristown, New Jersey, Stati Uniti, 07962
        • GSK Investigational Site
      • Summit, New Jersey, Stati Uniti, 07901
        • GSK Investigational Site
      • Wayne, New Jersey, Stati Uniti, 07470
        • GSK Investigational Site
    • New York
      • Babylon, New York, Stati Uniti, 11702
        • GSK Investigational Site
      • Buffalo, New York, Stati Uniti, 14215
        • GSK Investigational Site
      • Buffalo, New York, Stati Uniti, 14209
        • GSK Investigational Site
      • Mineola, New York, Stati Uniti, 11501
        • GSK Investigational Site
      • New York, New York, Stati Uniti, 10032
        • GSK Investigational Site
      • New York, New York, Stati Uniti, 10025
        • GSK Investigational Site
      • New York, New York, Stati Uniti, 10021
        • GSK Investigational Site
      • New York, New York, Stati Uniti, 10029
        • GSK Investigational Site
      • Troy, New York, Stati Uniti, 12180
        • GSK Investigational Site
      • West Islip, New York, Stati Uniti, 11794
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28203
        • GSK Investigational Site
      • Charlotte, North Carolina, Stati Uniti, 28080
        • GSK Investigational Site
      • Hickory, North Carolina, Stati Uniti, 28601
        • GSK Investigational Site
      • Statesville, North Carolina, Stati Uniti, 28625
        • GSK Investigational Site
    • North Dakota
      • Grand Forks, North Dakota, Stati Uniti, 58201
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, Stati Uniti, 44304
        • GSK Investigational Site
      • Bryan, Ohio, Stati Uniti, 43506
        • GSK Investigational Site
      • Cincinnati, Ohio, Stati Uniti, 45219
        • GSK Investigational Site
      • Cleveland, Ohio, Stati Uniti, 44106
        • GSK Investigational Site
      • Fairview Park, Ohio, Stati Uniti, 44126
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73103
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, Stati Uniti, 73109
        • GSK Investigational Site
    • Oregon
      • Corvalis, Oregon, Stati Uniti, 97330
        • GSK Investigational Site
      • Hillsboro, Oregon, Stati Uniti, 97123-4117
        • GSK Investigational Site
      • Portland, Oregon, Stati Uniti, 97220
        • GSK Investigational Site
      • Portland, Oregon, Stati Uniti, 97223
        • GSK Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, Stati Uniti, 15009
        • GSK Investigational Site
      • Greensburg, Pennsylvania, Stati Uniti, 15601
        • GSK Investigational Site
      • Hershey, Pennsylvania, Stati Uniti, 17033
        • GSK Investigational Site
      • Langhorne, Pennsylvania, Stati Uniti, 19047
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Stati Uniti, 19102
        • GSK Investigational Site
      • Ridley Park, Pennsylvania, Stati Uniti, 19078
        • GSK Investigational Site
      • West Chester, Pennsylvania, Stati Uniti, 19380
        • GSK Investigational Site
      • Wynnewood, Pennsylvania, Stati Uniti, 19096
        • GSK Investigational Site
      • Wyomissing, Pennsylvania, Stati Uniti, 19610
        • GSK Investigational Site
    • Rhode Island
      • Cranston, Rhode Island, Stati Uniti, 02920
        • GSK Investigational Site
      • Pawtucket, Rhode Island, Stati Uniti, 02860
        • GSK Investigational Site
      • Westerly, Rhode Island, Stati Uniti, 02891
        • GSK Investigational Site
    • South Carolina
      • Greer, South Carolina, Stati Uniti, 29651
        • GSK Investigational Site
      • Spartanburg, South Carolina, Stati Uniti, 29302
        • GSK Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • GSK Investigational Site
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38301
        • GSK Investigational Site
      • Memphis, Tennessee, Stati Uniti, 38120
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Stati Uniti, 78705
        • GSK Investigational Site
      • Beaumont, Texas, Stati Uniti, 77702
        • GSK Investigational Site
      • Corpus Christi, Texas, Stati Uniti, 78404
        • GSK Investigational Site
      • Dallas, Texas, Stati Uniti, 75230
        • GSK Investigational Site
      • Dallas, Texas, Stati Uniti, 75231
        • GSK Investigational Site
      • Houston, Texas, Stati Uniti, 77074
        • GSK Investigational Site
      • Houston, Texas, Stati Uniti, 77090
        • GSK Investigational Site
      • Humble, Texas, Stati Uniti, 77338
        • GSK Investigational Site
      • Lubbock, Texas, Stati Uniti, 79410
        • GSK Investigational Site
      • McKinney, Texas, Stati Uniti, 75069
        • GSK Investigational Site
      • Odessa, Texas, Stati Uniti, 79761
        • GSK Investigational Site
      • Odessa, Texas, Stati Uniti, 79764
        • GSK Investigational Site
      • Orange, Texas, Stati Uniti, 77630
        • GSK Investigational Site
      • Tyler, Texas, Stati Uniti, 75701
        • GSK Investigational Site
      • Waco, Texas, Stati Uniti, 76712
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84124
        • GSK Investigational Site
    • Virginia
      • Arlington, Virginia, Stati Uniti, 22204
        • GSK Investigational Site
      • Chesapeake, Virginia, Stati Uniti, 23510
        • GSK Investigational Site
      • Galax, Virginia, Stati Uniti, 24333
        • GSK Investigational Site
      • Richlands, Virginia, Stati Uniti, 24641
        • GSK Investigational Site
      • Richmond, Virginia, Stati Uniti, 23249
        • GSK Investigational Site
      • Richmond, Virginia, Stati Uniti, 23294
        • GSK Investigational Site
      • Springfield, Virginia, Stati Uniti, 22151
        • GSK Investigational Site
    • Washington
      • Burien, Washington, Stati Uniti, 98166
        • GSK Investigational Site
    • West Virginia
      • Huntington, West Virginia, Stati Uniti, 25701
        • GSK Investigational Site
    • Wisconsin
      • Beloit, Wisconsin, Stati Uniti, 53511
        • GSK Investigational Site
      • Madison, Wisconsin, Stati Uniti, 53792
        • GSK Investigational Site
      • Marshfield, Wisconsin, Stati Uniti, 54449
        • GSK Investigational Site
      • Milwaukee, Wisconsin, Stati Uniti, 53215
        • GSK Investigational Site
      • Wausau, Wisconsin, Stati Uniti, 54401
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Men and women age 18 years or older
  • History of symptomatic atrial fibrillation (either paroxysmal or persistent)
  • Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

  • Permanent (chronic) atrial fibrillation
  • Antiarrhythmic drug therapy which cannot be stopped
  • Use of amiodarone with prior 6 months
  • History of unsuccessful cardioversion
  • History of certain cardiovascular conditions or cardiac surgery within prior 6 months
  • History of stroke within prior 6 months
  • Implanted cardio-defibrillator
  • Certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolic conditions, or cancer (except non-melanoma skin cancer)
  • Poorly controlled diabetes

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Sperimentale: omega-3-acid ethyl esters
Droga: omega-3-acid ethyl esters

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
Lasso di tempo: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter.
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
Lasso di tempo: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter.
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
Lasso di tempo: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
Lasso di tempo: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
Lasso di tempo: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
Lasso di tempo: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)
Lasso di tempo: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)
Lasso di tempo: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter
Lasso di tempo: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.
From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter
Lasso di tempo: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.
From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)
Lasso di tempo: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.
From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)
Lasso di tempo: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.
From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period
Lasso di tempo: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.
From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period
Lasso di tempo: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.
From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period
Lasso di tempo: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.
From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2006

Completamento primario (Effettivo)

1 gennaio 2010

Completamento dello studio (Effettivo)

1 gennaio 2010

Date di iscrizione allo studio

Primo inviato

20 novembre 2006

Primo inviato che soddisfa i criteri di controllo qualità

20 novembre 2006

Primo Inserito (Stima)

22 novembre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 gennaio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 dicembre 2016

Ultimo verificato

1 dicembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • OM8 Afib

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dati/documenti di studio

  1. Modulo di consenso informato
    Identificatore informazioni: OM8 Afib
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Set di dati del singolo partecipante
    Identificatore informazioni: OM8 Afib
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Modulo di segnalazione del caso annotato
    Identificatore informazioni: OM8 Afib
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Specifica del set di dati
    Identificatore informazioni: OM8 Afib
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocollo di studio
    Identificatore informazioni: OM8 Afib
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Piano di analisi statistica
    Identificatore informazioni: OM8 Afib
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Rapporto di studio clinico
    Identificatore informazioni: OM8 Afib
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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